Companies importing printed packaging, plastics, textiles, leather goods, and other colored or coated products into the European Union could face new chemical restrictions as the European Chemicals Agency (ECHA) examines whether two carcinogenic substances associated with dyes, inks, and UV-cured materials remain in imported articles.
ECHA opened a call for evidence on 23 September on a draft screening report concerning 4,4'-bis(dimethylamino)-4''-(methylamino)trityl alcohol, CAS 561-41-1, when it contains at least 0.1% Michler’s ketone or Michler’s base.
But the potential regulatory implications extend beyond products containing trityl alcohol itself.
ECHA’s preliminary conclusion is that, if further regulatory action is warranted, it may be more appropriate to target Michler’s ketone and Michler’s base directly because the substances can occur through several different pathways involving dyes, pigments, inks, and coatings.
That distinction could significantly broaden the products and supply chains companies need to examine.
Three chemicals are at the center of ECHA’s review.
The screening concerns:
4,4'-bis(dimethylamino)-4''-(methylamino)trityl alcohol, sometimes referred to as trityl alcohol in ECHA's report, CAS 561-41-1, EC 209-218-2;
Michler’s ketone, EC 202-027-5; and
Michler’s base, EC 202-959-2.
The trityl alcohol entry is on the REACH Authorisation List when it contains at least 0.1% Michler’s ketone or Michler’s base. Its sunset date was 1 May 2025. ECHA identifies the substance in that form as a substance of very high concern (SVHC) because of carcinogenic properties. Michler’s ketone and Michler’s base are themselves classified as Carcinogenic Category 1B and identified as SVHCs.
Importantly, ECHA says pure trityl alcohol itself does not have a harmonized carcinogenic classification. The concern arises from the presence of Michler’s ketone or Michler’s base at or above the specified concentration.
The issue reaches well beyond chemical manufacturers
The draft report points to the role of the three substances in triarylmethane dye chemistry.
Michler’s ketone is used to manufacture dyes and pigments including crystal violet, methyl violet, malachite green and Victoria blue. It can also function as a photoinitiator or photosensitiser in UV-cured inks and adhesives. Michler’s base has a similar upstream role in dye production, while trityl alcohol is used as a specialty dye precursor.
This means companies may need to look beyond whether one of the chemicals was deliberately added to a finished product.
ECHA says Michler’s ketone and Michler’s base can remain as residual impurities, unreacted intermediates, or degradation products associated with dyes, pigments, inks, and coatings. Michler’s ketone can additionally remain following its use as a photoinitiator in UV-cured systems.
That creates a potentially difficult supply chain question: a company may not intentionally specify Michler’s ketone or Michler’s base in a product, yet residues could still enter the finished article through the colorant, ink, adhesive, or coating used during manufacturing.
Packaging, labels, and paper products could be particularly relevant
ECHA identifies printing inks, pigments, and paper colorants used on labels and packaging as potential sources. UV-curing printing inks can also be used on paper, metal, and plastic films.
While these uses no longer take place in Europe for the Annex XIV trityl alcohol entry because no authorization was sought, ECHA says imported articles remain a potential route by which trityl alcohol, Michler’s ketone, or Michler’s base could enter the European Economic Area (EEA).
Paper products are another area under scrutiny. ECHA identifies possible links to colored paper, fiber dyeing, printing inks, carbonless paper, pressure-sensitive paper, and thermal copy paper. The report also examines historical measurements of Michler’s ketone in paper and paperboard used for food packaging, although ECHA notes that much of the available occurrence data is old. rest_axiv_entry_56_screening_re…
Plastics, electronics, and UV-cured materials also enter the picture
The potential product scope is broader still.
ECHA's review identifies possible applications involving UV-curable resins for 3D printing, photocurable dental materials and bone cements, coatings and adhesives, flexographic and offset printing inks, photosensitive dry films used in electronics, and optical-fiber cladding materials.
The Agency's own SCIP database provides another indication of where companies may need to look. As of June 2026, notifications associated trityl alcohol mainly with printed labels, Michler’s ketone mainly with electric cables and plastic components, and Michler’s base mainly with printed labels and inks. ECHA cautions, however, that SCIP data can contain generic or potentially erroneous entries and does not by itself establish that a substance is actually present in a particular product.
Textile and leather supply chains may also be relevant. Triarylmethane dyes have been used on wool, silk, cotton, and acrylic fibers, while dyes and pigments associated with these substances can also be used to color leather.
Imported products are the regulatory pressure point
The distinction between European production and imports is important.
Once an Annex XIV sunset date has passed, REACH Article 69(2) requires ECHA to consider whether risks from the substance in articles are adequately controlled and, if they are not, to prepare an Annex XV restriction dossier. Manufacturing outside the EU is outside the scope of REACH authorization, but articles imported into the EU can be subject to the subsequent restriction investigation.
ECHA currently says the evidence is insufficient to determine how prevalent Michler’s ketone and Michler’s base are in articles on today's EU market. It also cautions that the available residue information is limited and, in some cases, approximately 20 years old.
Nevertheless, because the chemicals may occur in paper, plastics, textiles, and leather and because of their carcinogenic properties, ECHA says risks to human health from consumer exposure cannot currently be excluded.
That uncertainty is precisely what the current call for evidence is intended to address.
Why companies should examine their supply chains now
There is no new REACH restriction yet. ECHA is still gathering evidence, and the call for evidence does not replace the formal public consultation that would accompany a future restriction proposal.
But waiting for a restriction proposal could leave companies trying to answer difficult supply chain questions after the regulatory scope has already begun to crystallize.
Importers and manufacturers of products using triarylmethane dyes, printing inks, colored paper, printed labels, packaging, UV-cured inks or adhesives, coatings, plastics, electrical components, textiles, or leather should consider whether their suppliers can identify the dyes and chemical intermediates used upstream.
The challenge is that conventional declarations based only on intentionally added ingredients may not be enough. ECHA is specifically examining chemicals that can occur as residual impurities or degradation products. Companies may therefore need information further upstream—from dye, pigment, ink, coating, and adhesive suppliers—to determine whether Michler’s ketone or Michler’s base could remain in the finished article.
For importers, particularly those sourcing colored, printed, or coated products from outside the EEA, that makes supplier visibility increasingly important.
The 4 November deadline gives industry an opportunity to shape the evidence
ECHA is asking stakeholders to provide information on whether the substances or their residues are still present in articles sold on the EU market, the types of imported articles involved, their concentrations, available analytical methods, and other evidence that could help determine whether further regulatory action is justified.
The consultation closes at 23:59 Helsinki time on 4 November 2026.
Companies with relevant analytical results, supplier information, or product data therefore have an immediate opportunity to contribute evidence before ECHA decides whether an Annex XV restriction dossier should be prepared.
For businesses that do not submit information, the same period provides an opportunity to begin mapping potential exposure: identify relevant products, trace dyes, pigments, inks, coatings, and adhesives through the supply chain, determine what information suppliers can provide, and identify where testing or additional documentation may be needed.
The most consequential point is not simply whether a product lists trityl alcohol as an ingredient. ECHA's draft assessment suggests that Michler’s ketone and Michler’s base themselves could become the focus of further regulatory action.
For companies selling printed, colored, coated, or UV-cured products into Europe, that makes the chemicals—and the upstream materials capable of introducing them—worth investigating now.